Engineer Senior
Posted: 04/30/2026
Job Number: 42204
Job Description
Engineer Senior
Hybrid
Summary:
Our company is seeking a contract electromechanical combination product Device Engineer. The Device Engineer will participate in design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.
Responsibilities:
Pay range is $37 - $42 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
Hybrid
Summary:
Our company is seeking a contract electromechanical combination product Device Engineer. The Device Engineer will participate in design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.
Responsibilities:
- Provide ongoing lifecycle management (LCM) support for electromechanical combination products, including post-market activities, design improvements, and cross-functional issue resolution to ensure product reliability and compliance.
- Lead complaint investigations by performing detailed failure analysis, identifying root causes, and developing data-driven action plans in collaboration with quality, manufacturing, and regulatory teams.
- Drive and manage quality system processes including CAPAs, deviations, and change controls, ensuring timely closure, robust documentation, and alignment with regulatory and internal requirements.
- Collaborate closely with external suppliers to support LCM activities, including issue resolution, component updates, root cause analysis, CAPAs and continuous improvement initiatives to maintain supply continuity and product performance.
- Manage change assessments driven by internal and external changes during the life cycle of the combination product
- Participate in and support cross-functional design reviews for combination product development.
- Provide design verification support for combination products, ensuring compliance with Quality System Requirements, Design Control (21 CFR 820.30), and ISO 13485.
- Lead and execute on-site testing and verification activities for electromechanical delivery systems and related platforms.
- Develop, review, and execute test protocols, reports, and technical documentation in accordance with design control and regulatory expectations.
- Perform data verification, analysis, and traceability reviews to ensure product performance meets user needs and design inputs.
- Partner cross-functionally with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.
- Master’s or Bachelor’s Degree in Engineering Discipline (Mechanical, Biomedical, Electrical) with 3-5 years (or 2 years with Masters) of professional experience in highly regulated environment (strong preference for medical device, biopharma and/or combination product experience).
- Experience with electromechanical systems, injection devices, medical devices or delivery platforms preferred.
- Demonstrated expertise in lifecycle management, data analysis, and protocol/report generation under design control.
- Strong understanding of materials coordination, supplier interaction, and lab testing logistics.
- Proven ability to work in cross-functional project teams, communicate technical results clearly, and lead execution to meet program milestones.
- Working proficiency in statistical analysis software (Minitab)
- Smartsheets proficiency is a plus.
- Ability to work independently and dynamically across functional teams
- Excellent written and verbal communication skills
- Must be capable of working on multiple projects in a deadline driven environment.
Pay range is $37 - $42 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
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